A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01258595
First received: December 10, 2010
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age

Primary Objective:

  • To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.
  • To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

Condition Intervention Phase
Influenza
Biological: High-Dose Trivalent Inactivated Influenza Vaccine
Biological: Trivalent Inactivated Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.

  • Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine [ Time Frame: Day 0 and Day 28 Post-vaccination ] [ Designated as safety issue: No ]
    Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.

  • Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]

    Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.

    Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.


  • Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine [ Time Frame: Day 0 and Day 28 post vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.


Secondary Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine [ Time Frame: Day 0 through Day 7 post-vaccination ] [ Designated as safety issue: No ]
    Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering


Enrollment: 300
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-Dose Trivalent Inactivated Influenza Vaccine Biological: High-Dose Trivalent Inactivated Influenza Vaccine
0.5 mL Intramuscular
Other Name: Fluzone® High-Dose
Active Comparator: Trivalent Inactivated Influenza Vaccine Biological: Trivalent Inactivated Influenza Vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®

Detailed Description:

Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination.

  Eligibility

Ages Eligible for Study:   50 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 50 to 64 years (inclusive) on the day of vaccination
  • Informed consent form has been signed and dated
  • Medically stable
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination

Exclusion Criteria:

  • Known pregnancy, or a positive urine pregnancy test
  • Currently breastfeeding a child
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw)
  • Receipt of seasonal or pandemic influenza vaccine in the past 6 months
  • Receipt of blood or blood-derived products in the past 3 months
  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated Influenza Vaccine or a vaccine containing any of the same substances
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy
  • Neoplastic disease or any hematologic malignancy
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • Personal history of Guillain-Barré Syndrome
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258595

Locations
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Maryland
Columbia, Maryland, United States, 21045
Ellicott City, Maryland, United States, 21042
United States, Montana
Missoula, Montana, United States, 59802
United States, Ohio
Cleveland, Ohio, United States, 44122
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01258595     History of Changes
Other Study ID Numbers: FIM09, UTN: U1111-1113-3648
Study First Received: December 10, 2010
Results First Received: September 19, 2011
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Trivalent Inactivated Influenza Vaccine
High-Dose Trivalent Inactivated Influenza Vaccine
Influenza vaccines

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014